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Jul 5, 2024 | 
mddionline.com | Donielle McCutcheon |Taylor Andelman
Recruiting and retaining study subjects remains a significant challenge for medical device companies that are innovating and sponsoring clinical trials, particularly when designing studies that reflect the diversity of the national population. Difficulties enrolling eligible study subjects can lead to significant study delays and can be costly for trial sponsors, extending the timeline that patients need to wait to obtain access to safe, effective, and important medical technologies.
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Jul 1, 2024 | 
mddionline.com | Donielle McCutcheon |Taylor Andelman
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Jan 8, 2024 | 
lexology.com | Meenakshi Datta |Brenna Jenny |Donielle McCutcheon |Catherine Y. Starks |Kwaku Akowuah |Matthew Guillod
In late December 2023, the U.S. District Court for the District of Columbia issued an order that has important implications for pharmaceutical manufacturers that offer co-pay assistance for eligible patients.
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Jul 17, 2023 | 
lexology.com | Meenakshi Datta |Stephanie P. Hales |Elizabeth Hardcastle |Donielle McCutcheon |William A. Sarraille |Catherine Y. Starks | +1 more
In the past two weeks, the Centers for Medicare & Medicaid Services (CMS) unveiled important details regarding implementation of the Medicare Drug Price Negotiation Program (Negotiation Program) under the Inflation Reduction Act (IRA).
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Jun 22, 2023 | 
pharmaceuticalonline.com | Donielle McCutcheon |Kim Schroer |Carol Houts |Satu Lakio
By Donielle McCutcheon and Kim Schroer, Sidley Austin LLP For emerging drug companies on a tight budget, an effective healthcare compliance program can save precious resources by establishing better oversight, controls, and monitoring of the company’s quality, R&D, clinical, and market access activities. Such a program should be implemented in precommercial stages and will prepare you for the regulated future ahead.
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Jun 9, 2023 | 
outsourcedpharma.com | Donielle McCutcheon |Kim Schroer |Louis Garguilo
Guest Column
| June 9, 2023
By Donielle McCutcheon and Kim Schroer, Sidley Austin LLP
In the rush to obtain final approval or clearance from the FDA, raise funds, develop compelling data, and preserve scarce cash, it can be tempting to put off investment in a healthcare compliance program.
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May 31, 2023 | 
lexology.com | Catherine Y. Starks |Meenakshi Datta |Elizabeth Hardcastle |Donielle McCutcheon |William A. Sarraille |Trevor L. Wear | +2 more
On May 23, 2023, the U.S. Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that addresses a variety of important drug pricing matters under the Medicaid Drug Rebate Program (MDRP).
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Mar 20, 2023 | 
lexology.com | Meenakshi Datta |Stephanie P. Hales |Elizabeth Hardcastle |Donielle McCutcheon |Catherine Y. Starks |Trevor L. Wear | +2 more
On March 15, the Centers for Medicare and Medicaid Services (CMS) made a series of important announcements regarding implementation of the Inflation Reduction Act (IRA). Most crucially, CMS issued new initial guidance on implementation of the Medicare Drug Price Negotiation Program (Medicare Drug Price Program), with public comments due April 14, 2023. Notably, CMS did not issue the initial guidance through notice and comment rulemaking.
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Feb 23, 2023 | 
lexology.com | Elizabeth Hardcastle |Meenakshi Datta |Stephanie P. Hales |Donielle McCutcheon |William A. Sarraille |Catherine Y. Starks | +2 more
On February 14, the U.S. Department of Health and Human Services (HHS) that the HHS Secretary had selected three new payment and service delivery models for testing by the Center for Medicare & Medicaid Innovation (CMS Innovation Center). HHS has directed the CMS Innovation Center to test whether these new models result in lower prescription drug costs, promote accessibility to therapies, and/or improve quality of care.
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Feb 14, 2023 | 
lexology.com | Meenakshi Datta |Donielle McCutcheon |William A. Sarraille |Trevor L. Wear |Elizabeth Hardcastle |Catherine Y. Starks
The U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG) has issued a Technical Assistance Brief (the Brief) identifying anticipated challenges the Centers for Medicare & Medicaid Services (CMS) will face in implementing the inflation-indexed rebates for Medicare Part B drugs under the Inflation Reduction Act (IRA). The Brief builds on findings from prior evaluations by HHS-OIG of potential Part B drug rebates.
